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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075517
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007

January 9, 2004
July 23, 2008
September 2003
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Response rate [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00075517 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
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Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

  • Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.

Secondary

  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the tolerance profile of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: docetaxel
  • Drug: gemcitabine hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:

    • Epidermoid carcinoma
    • Large cell carcinoma
    • Adenocarcinoma
  • Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease
  • Inoperable disease
  • Measurable disease

    • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Absolute neutrophil count at least 2,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than normal
  • Transaminases no greater than 1.5 times normal
  • Alkaline phosphatase no greater than 2.5 times normal

Renal

  • Creatinine no greater than 2.3 mg/dL

Cardiovascular

  • No uncontrolled cardiac insufficiency

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study therapy
  • No uncontrolled infection
  • No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No grade 3 or 4 brain disorder
  • No intolerance to polysorbate 80 or cortisones

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy, including taxanes or gemcitabine
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to more than 20% of the bone marrow
  • No prior radiotherapy for lung cancer
  • At least 4 weeks since other prior radiotherapy and recovered

Surgery

  • No prior surgery for lung cancer

Other

  • More than 30 days since prior clinical trial participation
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00075517
CDR0000346806, FRE-GERCOR-DOCEGEM-B00-2, EU-20331
Not Provided
Not Provided
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Not Provided
Investigator: Philippe Terrioux, MD Clinique de Docteur Terrioux
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP